PURPOSE The first interim analysis of the phase III, randomized, placebo-controlled TITAN study showed that apalutamide significantly improved overall survival (OS) and radiographic progression-free survival in patients with metastatic castration-sensitive prostate cancer (mCSPC) receiving ongoing androgen deprivation therapy (ADT). Herein, we report final efficacy and safety results after unblinding and placebo-to-apalutamide crossover. METHODS Patients with mCSPC (N = 1,052) were randomly assigned 1:1 to receive apalutamide (240 mg QD) or placebo plus ADT. After unblinding in January 2019, placebo-treated patients were allowed to receive apalutamide. Efficacy end points were updated using the Kaplan-Meier method and Cox proportional-hazards model without formal statistical retesting and adjustment for multiplicity. Change from baseline in Functional Assessment of Cancer Therapy-Prostate total score was assessed. RESULTS With a median follow-up of 44.0 months, 405 OS events had occurred and 208 placebo-treated patients (39.5%) had crossed over to apalutamide. The median treatment duration was 39.3 (apalutamide), 20.2 (placebo), and 15.4 months (crossover). Compared with placebo, apalutamide plus ADT significantly reduced the risk of death by 35% (median OS not reached v 52.2 months; hazard ratio, 0.65; 95% CI, 0.53 to 0.79; P < .0001) and by 48% after adjustment for crossover (hazard ratio, 0.52; 95% CI, 0.42 to 0.64; P < .0001). Apalutamide plus ADT delayed second progression-free survival and castration resistance ( P < .0001 for both). Health-related quality of life, per total Functional Assessment of Cancer Therapy-Prostate, in both groups was maintained through the study. Safety was consistent with previous reports. CONCLUSION The final analysis of TITAN confirmed that, despite crossover, apalutamide plus ADT improved OS, delayed castration resistance, maintained health-related quality of life, and had a consistent safety profile in a broad population of patients with mCSPC.

Johns Hopkins Center for the Prevention of Youth Violence Positive Behavioral Interventions and Supports (PBIS) is a universal, school-wide prevention strategy that is currently implemented in over 7,500 schools across the nation to reduce disruptive behavior problems through the application of behavioral, social learning, and organizational behavioral principles. PBIS aims to alter school environments by creating improved systems and procedures that promote positive change in student behavior by targeting staff behaviors. The present study examined the impact of PBIS on school organizational health using data from a large randomized controlled trial of PBIS conducted in 37 elementary schools. Longitudinal multilevel analyses on data from 2,507 staff revealed a significant effect of PBIS on staff reports of the schools' overall organizational health, resource influence, and staff affiliation over a 3-year period. This study indicated that changes in school organizational health are important consequences of the PBIS whole-school prevention model, and might in turn be a potential mediator of the effect of PBIS on student performance.

WHAT'S KNOWN ON THIS SUBJECT:Using a noncategorical approach to identifying children with special health care needs, previous research has shown that these individuals are at increased risk for poor health and high health care resource use. WHAT THIS STUDY ADDS:Children who screen positive for a special health care need because of functional limitations or behavioral health problems are at risk for low student engagement, disruptive behaviors, poor grades, and belowaverage performance on standardized achievement tests. abstract OBJECTIVE: To examine the associations between having a special health care need and school outcomes measured as attendance, student engagement, behavioral threats to achievement, and academic achievement. PARTICIPANTS AND METHODS:A total of 1457 children in the fourth through sixth grades from 34 schools in 3 school districts and their parents provided survey data; parents completed the Children With Special Health Care Needs Screener. School records were abstracted for attendance, grades, and standardized achievement test scores. RESULTS:Across 34 schools, 33% of children screened positive for special health care needs. After adjusting for sociodemographic and school effects, children with special health care needs had lower motivation to do well in school, more disruptive behaviors, and more frequent experiences as a bully victim. They experienced significantly lower academic achievement, as measured by grades, standardized testing, and parental-assessed academic performance. These findings were observed for children who qualified as having a special health care need because they had functional limitations attributed to a chronic illness or a behavioral health problem but not for those who qualified only because they took prescription medications. CONCLUSIONS:Specific subgroups of children with special health care needs are at increased risk for poor school outcomes. Health and school professionals will need to collaborate to identify these children early, intervene with appropriate medical and educational services, and monitor long-term outcomes.

Purpose To develop a practical, efficient, and valid pediatric global health measure that would be useful for clinical, quality improvement, and research applications. Methods Using the PROMIS mixed-methods approach for item bank development, we identified an item pool that was well understood by children as young as age 8 years, and tested its psychometric properties in an internet panel sample of 3,635 children 8–17 years-old and 1,807 parents of children 5–17 years-old. Results The final version of the pediatric global health measure included 7 items assessing general, physical, mental, and social health. Four of these items had the same wording as the PROMIS adult global health measure. Internal consistency was 0.88 for the child-report form and 0.84 for the parent form; both had excellent test-retest reliability. The measures showed factor invariance across age categories. There was no differential item functioning by age, gender, race, or ethnicity. Because the measure includes the general health rating question, it is possible to estimate the pediatric global health scale using this widely used single item. Conclusions The PROMIS Pediatric Global Health measure is a brief and reliable 7-item summary assessment of a child’s self-reported health. Future work will attempt to statistically link this pediatric form with the PROMIS adult global health measures to create a single global health metric that can be used across the life course.